Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients (TWEEP)

Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients. Monocentric Crossover Interventionnal Study.

Datas are lacking concerning weaning from mechanical ventilation for tracheostomized patients. In particular, the effect of different modalities of spontaneous breathing trials on respiratory effort has not been extensively described.

This crossover physiology study will include 18 tracheostomized patients ventilated for more than 72 hours.

The objective of this study is to compare the effect of three different modalities of SBTs on respiratory effort in tracheostomized patients. The modalities tested are : Pressure Support Ventilation (PSV level 5 cmH2O, PEEP 5 cmH2O), T-piece test and high-flow Oxygen. Each modality is applied in a randomized order, during 30 minutes. During every modality tested, esophageal and gastric pressure, expired CO2, and comfort will be monitored, in addition to standard monitoring. Based on esophageal pressure monitoring, patient's respiratory efforts can be calculated either by esophageal pressure-time product and work of breathing. Pressure generated by inspiratory muscles will also be assessed.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Procedure: Modality 1; Procedure: Modality 2; Procedure: Modality 3

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise Piquilloud Imboden, MER&PD; Phone Number: +41 79 556 68 27; Email: lise.piquilloud@chuv.ch
• Study Contact Backup: Name: Davy Cabrio; Phone Number: +41 79 556 69 56; Email: davy.cabrio@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Recruiting
      • Lausanne University Hospitals
      • Contact: Lise Piquilloud Imboden, PD&MER; Phone Number: +41 79 556 68 27; Email: lise.piquilloud@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients for whom a tracheostomy is planned
• Patients on invasive ventilation for >72 hours

Exclusion Criteria:

• Tracheostomy for upper airway obstruction or other disease
• Patients tracheostomized before current hospitalization
• Patients with Glasgow Coma Scale (GCS) < 8/10 after cardiac arrest
• Patients with GCS < 8/10 because of primary central neurologic disease
• Patients for whom therapeutic limitations have already been decided
• Patients for whom weaning from ventilation is not an objective
• Patients suffering from myasthenia gravis
• Patients with cardiac assistance device
• Patients with medullary lesion proximal to C5
• Patients for whom nasogastric tube insertion is contraindicated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Modality 1 - Washout - Modality 2 - Washout - Modality 3; Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities.	Procedure: Modality 1; Pressure support ventilation (PSV) modality; Procedure: Modality 2; T-Piece modality; Procedure: Modality 3; High-flow oxygen
OTHER: Modality 1 - Washout - Modality 3 - Washout - Modality 2; Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities.	Procedure: Modality 1; Pressure support ventilation (PSV) modality; Procedure: Modality 2; T-Piece modality; Procedure: Modality 3; High-flow oxygen
OTHER: Modality 2 - Washout - Modality 1 - Washout - Modality 3; Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities.	Procedure: Modality 1; Pressure support ventilation (PSV) modality; Procedure: Modality 2; T-Piece modality; Procedure: Modality 3; High-flow oxygen
OTHER: Modality 2 - Washout - Modality 3 - Washout - Modality 1; Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities.	Procedure: Modality 1; Pressure support ventilation (PSV) modality; Procedure: Modality 2; T-Piece modality; Procedure: Modality 3; High-flow oxygen
OTHER: Modality 3 - Washout - Modality 2 - Washout - Modality 1; Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities.	Procedure: Modality 1; Pressure support ventilation (PSV) modality; Procedure: Modality 2; T-Piece modality; Procedure: Modality 3; High-flow oxygen
OTHER: Modality 3 - Washout - Modality 1 - Washout - Modality 2; Three different 30-minute modalities of deventilation will be performed in a randomized order in each patient. Washout periods of 30 minutes will occur between tested modalities.	Procedure: Modality 1; Pressure support ventilation (PSV) modality; Procedure: Modality 2; T-Piece modality; Procedure: Modality 3; High-flow oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of pressure-time product of esophageal pressure	Quantification of inspiratory effort of the patient	Recorded every 5 minutes during each sequence and washout period, 180 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of work of breathing (WOB)	Total area of a Campbell diagram for esophageal pressure and volume during one respiratory cycle	Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of esophageal pressure drop	Maximum variation of esophageal pressure during respiratory cycles	Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of inspiratory muscle pressure (Pmus)	Pressure generated by patients' respiratory muscles	Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of transdiaphragmatic pressure (Ptransdiaph)	Difference between gastric and esophageal pressure. Reflect of pressure generated by diaphragm during inspiration	Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of tidal volume (VT)		Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of respiratory rate (RR)		Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of inspiratory airway flow		Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of ratio of inspiratory time over total duration of a breathing cycle (ti/ttot)		Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of Rapid Shallow Breathing Index (RSBI)	RR/VT - predictor during ventilation weaning of intolerance of SBT	Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of respiratory system compliance (Crs)	Capacity of total respiratory system to gain volume for a given pressure	Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of lungs compliance (CL)	Capacity of lungs to gain volume for a given pressure	Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of chest wall compliance (Ccw)	Capacity of lungs to gain volume for a given pressure	Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of transpulmonary pressure (Ptranspulm)	Alveolar pressure minus pleural pressure	Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of ratio of total dead space volume over tidal volume	Calculated by means of expired CO2 and arterial blood gas CO2	Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of total dead space volume	Calculated by means of expired CO2	Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of total Positive End-Expiratory Pressure (PEEPtot)	Airway pressure during end-expiratory ventilator occlusion	Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of heart rate	Standard monitoring	Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of blood pressure	Standard monitoring	Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of Plateau pressure (Pplat)	Airway pressure during end-inspiratory ventilator occlusion (corresponds to alveolar pressure)	Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of intrinsic Positive End-Expiratory Pressure (PEEPi)	PEEPi minus PEEP set on ventilator	Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Pulmonary strain	Measured as the ratio of tidal volume over functionnal residual capacity (FRV)	Recorded every 5 minutes during each sequence and washout period, 180 minutes
Evolution of Diaphragmatic excursion (DE)	Ultrasound measurement of diaphragm movement during inspiration	Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of Diaphragmatic thickening fraction (DTF)	Ultrasound measurement of diaphragm thickening during inspiration	Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of hematocrits	Mesured by arterial blood	Recorded at minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of Richmond Agitation/Sedation scale (RASS) score	Used in ICU to monitor neurologic changes in patients. Scale from -5 (unarousable) to +4 (combative). 0 is a calm and responsive patient.	Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of Borg dyspnea scale score	Numeric scale to quantify dyspnea from 0 to 10. 0 mean patient does not feel that breathing is difficult and 10 is a maximal dyspnea. Measured twice during each Spontaneous Breathing Trial	Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes
Evolution of Multidimensionnal dyspnea scale (MDP) score	Score to quantify comfort, dyspnea and assess respiratory effort as perceived by patient. This scale contains multiple items, divided in two dimensions : sensory and affective. Sensory dimension contains : intensity on a scale of 0 to 10 of five sensory qualities (physical breathing effort, air hunger, tightness, mental breathing effort, hyperpnoea) Affective dimension contains : a breathing discomfort scale (scale of 0 to 10) Measured once during each Spontaneous Breathing Trial	Recorded at minute 30 of each three spontaneous Breathing Trial, 90 minutes

Collaborators and Investigators

• Sponsor: Piquilloud Imboden Lise
• Investigators: Principal Investigator: Lise Piquilloud Imboden, MER&PD, University of Lausanne Hospitals

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 8, 2019
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (ACTUAL): February 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Ventilation; Tracheotomy; Work of breathing; Esophageal pressure; Difficult weaning; Spontaneous Breathing Test; Esophageal pressure time-product; Difficult weaning from mechanical ventilation; Ventilation weaning
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: TWEEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No